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. 2018 Dec 14:10:6985-6996.
doi: 10.2147/CMAR.S185017. eCollection 2018.

Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study

Ji-Jin Yao  1   2 , Fan Zhang  2 , Guang-Shun Zhang  1 , Xiao-Wu Deng  1 , Wang-Jian Zhang  3 , Wayne R Lawrence  3 , Lu Zou  1 , Xiao-Shi Zhang  4 , Li-Xia Lu  1
Affiliations

Efficacy and safety of primary surgery with postoperative radiotherapy in head and neck mucosal melanoma: a single-arm Phase II study

Ji-Jin Yao et al. Cancer Manag Res. .

Abstract

Background: There still remains no well-established treatment strategy for head and neck mucosal melanoma (HNMM). We aim to evaluate the effectiveness and safety of primary surgery with postoperative radiotherapy for this disease.

Patients and methods: A single-arm, Phase II clinical trial was conducted at Sun Yat-Sen University Cancer Center. Patients with nonmetastatic, histologically proven HNMM were prospectively enrolled. Patients received primary surgery followed by intensity-modulated radiotherapy with an equivalent dose at 2 Gy per fraction of 65-70 Gy to CTV1 (high-risk regions including tumor bed) and 50-55 Gy to CTV2 (low-risk regions). Additional use of adjuvant chemotherapy (AC) depended on consultation from a multidisciplinary team. This trial is registered with ClinicalTrials.gov, number NCT03138642.

Results: A total of 33 patients were enrolled and analyzed between July 2010 and November 2016. There were 18 (54.5%) patients with T3 disease and 15 (45.5%) patients with T4a disease. The median age at diagnosis was 58 years (range 27-83 years), and 61% of the cohort were males. The overall median follow-up duration was 25.3 months (range 5.3-67.1 months). The 3-year overall survival (OS), local relapse-free survival (LRFS), regional relapse-free survival (RRFS), and distant metastasis-free survival (DMFS) rates were 44.4, 91.7, 78.1, and 41.7%, respectively. Patients with T4a disease showed significantly inferior OS (P=0.049) and DMFS (P=0.040) than those with T3 disease. Prophylactic neck radiation (PNR) was nearly associated with superior RRFS (P=0.078). However, there was no significant difference in OS, LRFS, RRFS, and DMFS for patients treated with or without AC (P>0.05 for all). Toxicities were generally mild to moderate.

Conclusion: Primary surgery with postoperative radiotherapy yielded excellent local control and acceptable toxicity profile for HNMM. Nevertheless, high rates of distant metastases resulted in limited survival.

Keywords: efficacy; head and neck mucosal melanoma; postoperative radiotherapy; primary surgery; safety.

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Conflict of interest statement

Disclosure The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Kaplan–Meier analysis of (A) OS, (B) local relapse-free survival, (C) regional relapse-free survival, and (D) distant metastasis-free survival in the total population. Abbreviations: OS, Abbreviations.
Figure 2
Figure 2
Kaplan–Meier analysis of (A) OS and (B) distant metastasis-free survival for patients with stage T3 vs stage T4a; (C) regional relapse-free survival for patients treated with or without prophylactic neck radiation; and (D) overall survival for patients treated with or without adjuvant chemotherapy. Abbreviation: OS, Abbreviations.
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